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What is Test Method Validation? Understand the Importance of Verifying the Performance of a Medical Device


    One of the frequently cited FDA observations includes discrepancies and questions around Test Method Validation (TMV). Addressing it may become very difficult to deal with. Many regulatory, quality assurance professionals, and others involved in device compliance, unfortunately, lack the necessary knowledge and expertise. They require a better awareness of what validation involves, as well as the validation process itself to ensure adequacy and reliability of their test methods.

    What is Test Method Validation?

    Tests or inspections are defined as the process of inspecting a manufactured product for flaws and ensuring that it performs as intended. The set of procedures created to conduct the tests are known as test methods. Test Method Validation is the process of establishing, by objective evidence, that a test method consistently generates the appropriate result needed to meet the intended usage.

    The Importance of Test Method Validation

    During the design verification and design validation phases, numerous tests are performed on the medical device to determine that the defined requirements and intended use have been met using objective evidence. If the test methods for the numerous tests undertaken throughout the design verification and validation phase cannot be objectively justified, the test results are considered suspect.

    The medical device's quality, reliability, and durability may suffer as a result, and the end user's intended use will be compromised. If the test methods aren't validated, the results of all tests and inspections should be verified to ensure that the data is correct. As a result, the expense of quality will rise even more.

    Manufacturers, suppliers, clinicians, and users must all be cautious, because injury caused by unforeseen conditions can result in legal action. Inadequate test method validation can have severe consequences, and cost your company tens of millions of dollars.

    Validation Vs Verification

    Validation is closely tied to the related topic of verification, but it is critical to understand the difference. Validation is concerned with the end result, while verification is concerned with each element of a device meeting the appropriate requirements and standards.

    FDA Observations About Test Method Validation Discrepancies

    Here are some observations about test method validation discrepancies cited in the FDA's warning letters.

    Firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165e)

    Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and testing has not been adequately validated and approved according to established procedures, as required by 21 CFR 820.75(a).

    Failure to establish and maintain adequate procedure for changes to a specification, method, process or procedure. Such changes shall be verified or, where appropriate, validated according to 21 CFR 820.75 as required or as required by 21 CFR 820.70(b).

    Prepare Your Team

    The FDA's warning letters above serve as warnings that failing to validate medical device test methods can result in product recalls and financial consequences. Quality is projected as the sole weapon for every medical device manufacturer to thrive in the current and future market scenarios. So, it's important to create and maintain a suitable organizational structure to ensure that devices are created and manufactured in line with the regulations, ensuring that the product is safe, pure, and effective for patients. Validation of test methods plays an important part in assuring the validation of medical devices.

    Understanding the following areas is crucial to all those involved in analysis and testing, design and development, engineering, quality and manufacturing.

    • The elements of test method validation.
    • Precision and accuracy of test methods.
    • The limit to detection and quantification.
    • Specificity, linearity and range.
    • Robustness, repeatability and reproducibility of test methods.
    • Calibration and Preventive maintenance.
    • Life Cycle of Method Validation.
    • Quality System Regulation, 21 CFR Part 820, and ISO 13485 - Overview
    • When should Methods be Validated?
    • Qualification vs Validation
    • Types of Test Method Validations
    • How to perform successful test method validations
    • How to ensure your inspection of verification is effective
    • Detailing real-life case studies
    • Understanding global reference standards for test method validation
    • FDA requirements for TMV
    • How to prove your inspection method is repeatable and reliable

    Learn More

    If you are interested in learning more about test method validation, check out the online webinars we are currently offering. Whether you want to learn test method validation basics, set up statistically justified sampling plans for process validation, or scrutinize test method validation to verify the performance of a medical device, take that next step towards one of the most important aspects in medical device industry and you'll see the true significance of test method validation.